Testing an Intervention in Irritative Contact Dermatitis

Not Applicable

Recruiting

• Conditions: Contact Dermatitis Irritant; Contact Dermatitis
• Interventions: Other: Emollient cream treatment; Other: no treatment

• Registration Number: NCT06189144
• Lead Sponsor: University of Split, School of Medicine

Brief Summary

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.

Detailed Description

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-09-13
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• healthy volunteers who gave written informed consent

Exclusion Criteria

• · skin cancer

  • skin disease
  • skin damage on measurement sites
  • use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  • use of drugs that may cause photosensitivity
  • use of emollients three days prior the inclusion in the trial
  • non-adherence to the trial protocol
  • exposure to artificial and excessive natural ultraviolet (UV) radiation
  • pregnancy and lactation
  • history of vitiligo, melasma and other pigmentation and photosensitivity disorders
  • immunosuppression
  • allergic or irritant reactions to the constituents of the cream

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	Emollient cream treatment	SLS irritation model and Treatment
placebo comparator	no treatment	SLS irritation model and No Treatment

Primary Outcome Measures

Name	Time	Method
hydration measurement with corneometer probe	through study completion, an average of 1 year	corneometer assessed stratum corneum hydration level
TEWL measurement with Khazaka probe	through study completion, an average of 1 year	Transepidermal water loss
erythema measured with mexameter	through study completion, an average of 1 year	mexameter assessed redness

Secondary Outcome Measures

Name	Time	Method
clinical score according to dermatologist scale	through study completion, an average of 1 year	Skin response to irritation and treatment will be assessed using a five-point scale to describe changes in skin erythema, roughness, scaling, oedema, and fissure

Trial Locations

Locations (1)

School of Medicine; 🇭🇷 Split, Croatia